The final version of ICH E6(R3) was finally released last month! This update (an overhaul, really!) emphasizes flexibility, risk-based approaches, and modern technology use in clinical trials.?Check out my assessment of the updates with some helpful links to learn more!
Ritchie Scientific Consulting, LLC
生物技术研究
Woburn,MA 123 位关注者
Ritchie Scientific Consulting, LLC delivers with the passion that patients deserve.
关于我们
Ritchie Scientific Consulting, LLC provides strategic medical writing support for pharmaceutical and medical device companies.
- 网站
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https://www.ritchiescientificconsulting.com
Ritchie Scientific Consulting, LLC的外部链接
- 所属行业
- 生物技术研究
- 规模
- 1 人
- 总部
- Woburn,MA
- 类型
- 私人持股
- 创立
- 2017
- 领域
- Regulatory Writing、Global Submissions、Scientific Communications、Strategic Project Management、NDAs、INDs、BLAs、Publications、Conference Support和Vendor Oversight
地点
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主要
US,MA,Woburn,01801
Ritchie Scientific Consulting, LLC员工
动态
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Curious about how regulatory submissions are organized? Check out my newest blog post "Basics of the Common Technical Document (CTD)". Learn the essentials and why this global format is key to successful submissions! #MedicalWriting #RegulatoryAffairs https://lnkd.in/eq2YXDnR
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Happy New Year! I have a couple of deals on my courses going on now: Regulatory Medical Writing Basics: Only $9.99 (lowest price available on Udemy) for the next 5 days with coupon code "HAPPYNEWYEAR2025" https://lnkd.in/edhrPpq9 Writing an Effective Clinical Trial Protocol (brand new!): $97 if you register during the month of January (price will go up to $147 in February). You can start the course at any time and access is unlimited! https://lnkd.in/eyR6BxxW
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I had the honor of leading a roundtable followed by a webinar for the American Medical Writers Association on the topic of Avoiding Burnout in Medical Writing. I decided to turn this into a 3-part blog series on my website. Check it out at the link below! I would love your thoughts and any tips you have to avoid burnout as a medical writer! https://lnkd.in/e2W_2mag
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It’s been a great few days in New Orleans for the annual American Medical Writers Association meeting!
Looking forward to leading a roundtable this morning at #amwa2024!
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I am so excited to announce the official launch of my new online course - Developing a Reviewer-Friendly and Submission-Ready Clinical Study Report (CSR)! Check it out here: https://lnkd.in/eAhaJygy
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My online course "Regulatory Medical Writing Basics" has now helped 300 students in 37 countries! Check it out here: https://lnkd.in/esk7X7ET
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Hey friends! I'm STRONGLY considering creating an online course or masterclass to go through all the tools in Microsoft Word that are important for regulatory/technical writers (eg, building out a template, attaching a template to a document, table formatting, keyboard shortcuts, tools for collaboration). Just curious--is this something that might be helpful? I've taken a lot of online MS Word classes (and learned a LOT from them), but a lot of the content just isn't relevant for me, so I'd like to create something very focused for those of us creating technical documents. I would love your thoughts! If something like this existed, what would you hope to learn?